What is often forgotten is that Mesoblast Covid-19 ARDS RCT is funded by NIH, they have a strong voice.
So, the FDA cannot just do what they want e.g. as per Ryoncil non-approval
Both NIH and FDA are part of the PHEMCE
Ann: Phase 3 Trial in COVID-19 ARDS Surpasses 50% Enrollment, page-351
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